Merck & Co. announced Wednesday that a Phase III study of Keytruda (pembrolizumab) for the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) met a primary endpoint of overall survival (OS) in patients whose tumours expressed PD-L1. The company noted that the drug is the first anti-PD-1 therapy to show an OS benefit in this setting.
In the KEYNOTE-048 trial, 825 patients were randomised to receive Keytruda monotherapy, Keytruda plus cisplatin or carboplatin, in combination with 5-fluorouracil (5-FU), or Merck KGaA's Erbitux (cetuximab) plus cisplatin or carboplatin, in combination with 5-FU. The study's dual primary endpoints were OS and progression-free-survival (PFS), while secondary goals included PFS at six months and 12 months, and objective response rate.
Merck noted that at the interim analysis, treatment with Keytruda monotherapy resulted in significantly longer OS compared to Erbitux in combination with platinum chemotherapy plus 5-FU, which is the current standard of care for HNSCC in the first-line treatment setting. However, the company noted that at the interim analysis, the dual-main goal of PFS for patients whose tumours expressed PD-L1 had not been reached.
The trial is set to continue to evaluate Keytruda monotherapy and Keytruda in combination with platinum chemotherapy plus 5-FU. Merck indicated that the results will be presented at an upcoming medical meeting and submitted to global regulatory authorities.
Keytruda is currently approved in the US for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumour response rate and durability of response, with Merck reporting last year that Keytruda failed to extend OS in previously treated patients with recurrent or metastatic HNSCC.
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